Evaluating Improvised Chest Drainage Techniques in Conflict Zones

Safety and Efficacy of Improvised Chest Tube Drainage in the Absence of Conventional Systems: a Prospective Single-Center Study in Emergency and Conflict Zones in Sudan

This study examines the use of improvised chest drainage systems in managing chest trauma at Wad Madani Teaching Hospital, a low-resource and conflict-affected setting. Due to a shortage of standard chest tubes and underwater seal systems, healthcare providers have adapted by using nasogastric (NG) tubes as chest drains and IV drip sets as makeshift underwater seals.

The study aims to evaluate the safety, effectiveness, and feasibility of these improvised methods compared to traditional chest drainage techniques. Primary outcomes will include lung re-expansion success, infection rates, and hospital stay length. By assessing patient outcomes, this study seeks to determine if these adapted techniques can provide a viable alternative for trauma care in resource-limited settings, potentially guiding practices in similar environments globally.

Study Overview

• Status: Completed
• Conditions: Pneumothorax; Hemothorax; Flail Chest; Hemopneumothorax; Traumatic; Thoracic Trauma

Detailed Description

This study explores the application of improvised chest drainage systems at Wad Manani Teaching Hospital for managing chest trauma in a low-resource, conflict-affected setting. Due to limited availability of standard medical supplies, an alternative approach has been adopted using nasogastric (NG) tubes as chest drains paired with intravenous (IV) drip sets, modified to act as underwater seals.

The primary aim is to assess the safety and effectiveness of these improvised systems in comparison to conventional chest tube drainage. By focusing on outcomes such as lung re-expansion success, infection rates, and recovery time, this study seeks to establish the clinical viability of improvised drainage systems in emergencies. Secondary evaluations include cost-effectiveness and the role of targeted staff training in improving procedural outcomes.

Study Approach:

This is a 6-months prospective observational study where patients with chest injuries are assigned to either a standard treatment group or an improvised treatment group. The improvised system involves inserting an NG tube as a chest drain connected to a modified IV drip set for underwater sealing. Standard sterile protocols are followed to reduce infection risk.

Data Collection & Analysis:

Data on each patient's clinical course and intervention will be recorded, focusing on primary outcomes like successful lung re-expansion and infection, and secondary outcomes, including procedural feasibility and cost. Comparative statistical analysis will assess outcome differences between groups.

Ethical Compliance:

Institutional review board (IRB) approval will be obtained, with all patient data anonymized and securely stored. Informed consent will be obtained from all participants or their guardians.

Impact Statement:

By assessing improvised methods in trauma care within a resource-limited context, this study could inform adaptable practices for similar environments worldwide, potentially influencing trauma care protocols and patient outcomes in challenging settings.

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Sudan
  • Gezira
    • Wad Madani, Gezira, Sudan
      • Wad Madani teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include adult patients (18 years and75 years) presenting with chest trauma at Wad Madani Teaching Hospital, a low-resource and conflict-affected setting. Patients are eligible if they require chest drainage for conditions such as pneumothorax or hemothorax and are stable enough to undergo the procedure. Due to limited resources, chest drainage methods include both standard and improvised techniques. The study population represents individuals receiving trauma care in a low-resource setting, providing insights into the effectiveness and safety of adapted drainage techniques in resource-constrained environments

Description

Inclusion Criteria:

• Adults aged 18 years and older
• Patients presenting with chest trauma requiring chest drainage (e.g., pneumothorax, hemothorax)
• Willingness to provide informed consent to participate in the study -Stable enough to undergo chest X-ray or clinical assessment for lung re- expansion

Exclusion Criteria:

• Patients with pre-existing severe lung disease or significant comorbidities affecting chest drainage outcomes (e.g., advanced COPD, heart failure)
• Patients with prior chest surgery that may interfere with drainage outcomes
• Individuals with contraindications to chest tube insertion or NG tube placement
• Patients unwilling or unable to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Standard Treatment Group Label: Conventional Chest Drainage; This group includes patients with chest trauma who receive standard chest drainage using commercial chest tubes and underwater seal systems. This intervention follows established guidelines and protocols for chest drainage in trauma care. Patients in this group serve as the control group for comparing outcomes with those receiving improvised drainage systems.
Improvised Treatment Group Label: Improvised NG Tube Drainage; This group includes patients with chest trauma who receive chest drainage using improvised methods, specifically nasogastric (NG) tubes as chest drains and intravenous (IV) drip sets adapted to function as underwater seals. This alternative intervention is used due to resource constraints and aims to evaluate the safety and effectiveness of improvised methods in a low-resource, conflict-affected setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Successful Lung Re-expansion	The percentage of patients in each group (conventional vs. improvised chest drainage) who achieve full lung re-expansion as confirmed by chest X-ray.	Within 72 hours post-drainage

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Drainage-Related Infections	Number of participants with infections directly associated with the chest drainage procedure, including pleural or wound infections, documented by clinical signs and laboratory findings.	Up to 30 days post-procedure
Median Length of Hospital Stay	Median number of days from admission to discharge for each participant, allowing for the assessment of recovery duration associated with each drainage method.	From admission to discharge (typically within 30 days)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Score at Discharge	Patient satisfaction score assessed using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) at discharge, indicating the participant's perceived comfort and effectiveness of the chest drainage method used.	At discharge (up to 30 days post-procedure)

Collaborators and Investigators

• Sponsor: Sudan Medical Specialization Board
• Investigators: Study Chair: Hassan Ali Musa, Consultant, University of Gezira, Faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 10, 2023

Study Registration Dates

• First Submitted: November 7, 2024
• First Submitted That Met QC Criteria: November 9, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Underwater Seal System Alternatives; Chest Trauma; Improvised Chest Drainage; Nasogastric Tube Chest Drain; Low-Resource Trauma Care; Conflict Zone Healthcare; Pneumothorax Management; Hemothorax Treatment; Alternative Chest Tube Methods; Emergency Thoracic Intervention
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Thoracic Injuries; Pleural Diseases; Pneumothorax; Hemothorax; Hemopneumothorax; Flail Chest
• Other Study ID Numbers: WADMAD-ICDS-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly due to several considerations. First, the data includes sensitive personal health information, which must be protected to comply with privacy regulations and ethical standards. Additionally, the study is conducted in a low-resource setting, where data management and sharing capabilities may be limited. Ensuring the confidentiality and anonymity of participants is paramount, and sharing IPD could compromise these ethical obligations. Finally, the data will be used exclusively for the purpose of this study to inform clinical practice within the context of the local healthcare system, rather than for broader dissemination.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No